Pfizer says Bextra will have a serious warning that it can cause a potentially deadly skin reaction.
Has anyone else in your family ever had this kind of skin reaction?
What did your skin reaction look like when it first appeared?
The panel had not been asked to consider a second safety issue, called Stevens-Johnson Syndrome, a rare and potentially deadly skin reaction for which Bextra already has a boxed warning.
The attention deficit hyperactivity disorder drug, which is already on the market for sleepiness under the name Provigil, had caused one possible case of Stevens-Johnson Syndrome, a rare skin reaction.
In a note to investors released today, Prudential Equity Group's Timothy Anderson says that the FDA is likely to want even more information about this skin reaction, and that the agency might hold off on approving Galvus for as much as several more months.
Their minute hairs cause severe skin irritation, allergic reaction and, if breathed in, can be life threatening.
When a drug is likely to cause a severe side effect--say, an increased risk of heart attack, an allergic reaction that causes the skin to burn or liver failure--the standard practice is to warn patients and doctors about the product's labeling, and to send out warning letters to physicians who might prescribe the medicine.
The key ingredient is said to improve skin by setting off an elaborate chain reaction.
One can have skin reactions and rashes due to a reaction to bacterial, viral or fungal infection or an allergic reaction to medicines used to treat it.
According to Pfizer (nyse: PFE - news - people ), Bextra can cause a rare but sometimes life-threatening drug reaction called Stevens-Johnson Syndrome in which the skin, mouth, and eyes can become horribly blistered.
One developed a serious allergic reaction, two had kidney insufficiencies that reversed when they stopped and a few have had mild skin rashes that went away as they stayed on the treatment.
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